Field Safety Notices
Field Safety Notice - Feb 2016
29 February 2016
Audiences
Healthcare professional
Industry member
Product-type
Medical devices
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Table caption
Date of Notification | Title | FSN |
|---|---|---|
29 Feb 2016 | BioMatrix Flex and BioMatrix NeoFlex Drug Eluting Coronary Stent System, Biosensors Europe SA (HSA 600:41/01-223/16/01_43) | HSA 6004101-223-16-01_43 FSN [PDF, 1743 KB] (opens in new tab) |
29 Feb 2016 | WECK® AutoEndo5® Hem-o-lok® 5mm Automatic Endoscopic Hem-o-lok Applier, Weck Closure Systems (HSA 600:41/01-139/16/03_46) | HSA 6004101-139-16-03_46 FSN [PDF, 390 KB] (opens in new tab) |
29 Feb 2016 | Modulith SLX-F2, Storz Medical AG (HSA 600:41/01-133/16/02_25) | HSA 6004101-133-16-02_25 FSN [PDF, 354 KB] (opens in new tab) |
29 Feb 2016 | On-Board Imager® with CBCT, Varian Medical Systems, Inc (HSA 600:41/01-058/16/02_18) | HSA 6004101-058-16-02_18 FSN [PDF, 70 KB] (opens in new tab) |
29 Feb 2016 | Artis Zee and Artis Zeego, Siemens Healthcare GmbH (HSA 600:41/01-022/16/09_52) | HSA 6004101-022-16-09_52 FSN [PDF, 645 KB] (opens in new tab) |
26 Feb 2016 | BRAHMS Free beta-hCG Kryptor, BRAHMS GmbH (HSA 600:41/01-138/16/01_60) | HSA 6004101-138-16-01_60 FSN [PDF, 2685 KB] (opens in new tab) |
26 Feb 2016 | Berichrom® Antithrombin III, Siemens Healthcare Diagnostics Products GmbH (HSA 600:41/01-032/16/02_59) | HSA 6004101-032-16-02_59 FSN [PDF, 21 KB] (opens in new tab) |
26 Feb 2016 | Various Mid-Urethral Sling products, Boston Scientific Corporation (HSA 600:41/01-007/16/01_41) | HSA 6004101-007-16-01_41 FSN [PDF, 38 KB] (opens in new tab) |
25 Feb 2016 | ORTHO VISION® Analyzers and ORTHO VISION® Max Analyzers, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/07_57) | HSA 6004101-002-16-07_57 FSN [PDF, 67 KB] (opens in new tab) |
24 Feb 2016 | AQT90 FLEX Test Kit Box and CAL Cartridge, Radiometer Medical Aps (HSA 600:41/01-219/16/02_38) | HSA 6004101-219-16-02_38 FSN [PDF, 26 KB] (opens in new tab) |
24 Feb 2016 | TRACOE larynx stoma button, Tracoe Medical GmbH (HSA 600:41/01-149/16/01_49) | HSA 6004101-149-16-01_49 FSN [PDF, 116 KB] (opens in new tab) |
24 Feb 2016 | BARD TRUGUIDE® Disposable Coaxial Biopsy Needles, Bard Peripheral Vascular Inc (HSA 600:41/01-050/16/01_33) | HSA 6004101-050-16-01_33 FSN [PDF, 234 KB] (opens in new tab) |
24 Feb 2016 | PVC Trocar catheter CH 24, Redax S.p.A. (HSA 600:41/01-017/16/01_45) | HSA 6004101-017-16-01_45 FSN [PDF, 31 KB] (opens in new tab) |
23 Feb 2016 | Nellix Endo Vascular Aneurysm Sealing System, Endologix International Holdings B.V. (HSA 600:41/01-148/16/01_29) | HSA 6004101-148-16-01_29 FSN [PDF, 320 KB] (opens in new tab) |
23 Feb 2016 | VITROS® Immunodiagnostic Products Total β-hCG II Reagent Packs & Calibrators, Ortho-Clinical Diagnostic Inc(HSA 600:41/01-002/16/06_34) | HSA 6004101-002-16-06_34 FSN [PDF, 157 KB] (opens in new tab) |
22 Feb 2016 | Artis Zee & Artis Q/Q.zen, Siemens Healthcare GmbH (HSA 600:41/01-022/16/06_56) | HSA 6004101-022-16-06_56 FSN [PDF, 74 KB] (opens in new tab) |
22 Feb 2016 | AXIOM Artis & Artis zee systems, Siemens Healthcare GmbH (HSA 600:41/01-022/16/07_56) | HSA 6004101-022-16-07_56 FSN [PDF, 76 KB] (opens in new tab) |
22 Feb 2016 | VESA 75/ 100 adaptation with rotation, ITD GmbH (HSA 600:41/01-073/16/07_18) | HSA 6004101-073-16-07_18 FSN [PDF, 290 KB] (opens in new tab) |
22 Feb 2016 | Liko Universal SlingBar 350/ 450/ 600, Liko AB (HSA 600:41/01-076/16/02_17) | HSA 6004101-076-16-02_17 FSN [PDF, 537 KB] (opens in new tab) |
22 Feb 2016 | VIDAS TOXO IgM, Biomerieux SA (HSA 600:41/01-146/16/01_31) | HSA 6004101-146-16-01_31 FSN [PDF, 401 KB] (opens in new tab) |
22 Feb 2016 | AcuFocus KAMRA ACI 7000 Corneal Inlay, AcuFocus Inc (HSA 600:41/01-239/16/01_25) | HSA 6004101-239-16-01_25 FSN [PDF, 89 KB] (opens in new tab) |
19 Feb 2016 | Physio-Control QUIK-COMBO pacing/ defibrillation/ ECG electrodes, Physio-Control Inc (HSA 600:41/01-056/16/03_48) | HSA 6004101-056-16-03_48 FSN [PDF, 77 KB] (opens in new tab) |
18 Feb 2016 | Medical Head Lamp, Bistos co Ltd (HSA 600:41/01-291/16/01_54) | HSA 6004101-291-16-01_54 FSN [PDF, 63 KB] (opens in new tab) |
17 Feb 2016 | Universal Battery Charger II, Synthes GmbH (HSA 600:41/01-002/16/04_45) | HSA 6004101-002-16-04_45 FSN [PDF, 161 KB] (opens in new tab) |
17 Feb 2016 | VITROS 5600 Integrated Systems, Ortho-Clinical Diagnostic Inc (HSA 600:41/01-002/16/05_24) | HSA 6004101-002-16-05_24 FSN [PDF, 114 KB] (opens in new tab) |
17 Feb 2016 | Respironics Trilogy 100 System, Philips Respironics Inc (HSA 600:41/01-290/16/01_44) | HSA 6004101-290-16-01_44 FSN [PDF, 2498 KB] (opens in new tab) |
16 Feb 2016 | TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems, TRUMPF Medizin Systeme GmbH (HSA 600:41/01-279/16/01_37) Local Contact: Bio-Pointe Pte Ltd Contact no./Email: 67488911 | HSA 6004101-279-16-01_37 FSN [PDF, 184 KB] (opens in new tab) |
16 Feb 2016 | ARROW® Super Arrow-Flex® Percutaneous Sheath Introducer Set, Arrow International (HSA 600:41/01-139/16/01_51) Local Contact: Teleflex Medical Asia Pte Ltd Contact no./Email: 64393046 | HSA 6004101-139-16-01_51 FSN [PDF, 122 KB] (opens in new tab) |
16 Feb 2016 | Trilogy 100, Trilogy 200, Respironics, Inc. (HSA 600:41/01-087/16/01_40) Local Contact: Scanmed Technology (S) Pte Ltd Contact no./Email: 68723660 | HSA 6004101-087-16-01_40 FSN [PDF, 221 KB] (opens in new tab) |
16 Feb 2016 | CDI® H/S Cuvette, Terumo Cardiovascular System Corporation (HSA 600:41/01-028/16/01_36) Local Contact: Terumo Singapore Pte Ltd Contact no./Email: 62913603 | HSA 6004101-028-16-01_36 FSN [PDF, 268 KB] (opens in new tab) |
16 Feb 2016 | Borehole Port, Christoph Miethke GmbH & Co. KG (HSA 600:41/01-012/16/01_49) Local Contact: B. Braun Singapore Pte Ltd Contact no./Email: 62130933 | HSA 6004101-012-16-01_49 FSN [PDF, 341 KB] (opens in new tab) |
16 Feb 2016 | Aisys CS2 and upgraded Aisys anesthesia devices, Datex-Ohmeda, Inc (HSA 600:41/01-010/16/03_41) Local Contact: GE Healthcare Pte Ltd Contact no./Email: 62777668 | HSA 6004101-010-16-03_41 FSN [PDF, 84 KB] (opens in new tab) |
15 Feb 2016 | Oxoid Streptococcal Grouping Kit, Oxoid Limited (HSA 600:41/01-178/16/01_22) Local Contact: Thermo Scientific Microbiology Pte Ltd Contact no./Email: 64999992 | HSA 6004101-178-16-01_22 FSN [PDF, 110 KB] (opens in new tab) |
15 Feb 2016 | VESA 75/100 adaptation with rotation, ITD GmbH (HSA 600:41/01-133/16/01_18) Local Contact: Karl Storz Endoscopy Singapore Sales Pte Ltd Contact no./Email: 69229150 | HSA 6004101-133-16-01_18 FSN [PDF, 443 KB] (opens in new tab) |
15 Feb 2016 | Glidescope Titanium Single-Use Video Laryngoscope Blades, Verathon Medical Inc (HSA 600:41/01-076/16/01_19) Local Contact: Radiance Medical Systems Contact no./Email: 63162712 | HSA 6004101-076-16-01_19 FSN [PDF, 418 KB] (opens in new tab) |
15 Feb 2016 | Arietta 60 & Arietta 70, Hitachi Aloka Medical, Ltd (HSA 600:41/01-054/16/01_33) Local Contact: Hitachi Medical Systems (S) Pte Ltd Contact no./Email: 66020110 | HSA 6004101-054-16-01_33 FSN [PDF, 120 KB] (opens in new tab) |
15 Feb 2016 | Liquichek Specialty Immunoassay Control kit, Bio-Rad Laboratories (HSA 600:41/01-027/16/01_61) Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd Contact no./Email: 64904262 | HSA 6004101-003-16-01_61 FSN [PDF, 36 KB] (opens in new tab) |
15 Feb 2016 | 3.0T GEMflex Coil, GE Medical Systems LLC (HSA 600:41/01-010/16/02_25) Local Contact:GE Healthcare Pte Ltd | HSA 6004101-010-16-02_25 FSN [PDF, 76 KB] (opens in new tab) |
12 Feb 2016 | Panocell, Capture-R Ready-ID and Capture-R Ready-ID Extend II, Immucor Inc (HSA 600:41/01-033/16/02_60) Local Contact: Biomed Diagnostics Pte Ltd Contact no./Email: 62984347 | HSA 6004101-033-16-02_60 FSN [PDF, 123 KB] (opens in new tab) |
12 Feb 2016 | MitraClip Clip Delivery System, Evalve, LLC (DBA Abbott Vascular Inc.) (HSA 600:41/01-005/16/03_17) Local Contact: Abbott Laboratories Singapore Pte Ltd | HSA 6004101-005-16-03_17 FSN [PDF, 731 KB] (opens in new tab) |
12 Feb 2016 | Sekisui Diagnostics Acetaminophen L3K Assay, Sekisui Diagnostics P.E.I. Inc (HSA 600:41/01-005/16/02_58) Local Contact: Abbott Laboratories Singapore Pte Ltd | HSA 6004101-005-16-02_58 FSN [PDF, 26 KB] (opens in new tab) HSA 6004101-005-16-02_58 FSN [PDF, 756 KB] (opens in new tab) |
10 Feb 2016 | ADVIA Centaur Calibrator E, Siemens Healthcare Diagnostic Inc. (HSA 600:41/01-022/16/05_38) Local Contact: Siemens Healthcare Pte Ltd | HSA 6004101-022-16-05_38 FSN [PDF, 314 KB] (opens in new tab) |
10 Feb 2016 | Artis One System, Siemens Shenzhen Magnetic Resonance Ltd (HSA 600:41/01-022/16/04_46) | HSA 6004101-022-16-04_46 FSN [PDF, 552 KB] (opens in new tab) |
04 Feb 2016 | BIOSURE Ratcheted Driver, Smith & Nephew Inc (HSA 600:41/01-073/16/06_45) | HSA 6004101-073-16-06_45 FSN [PDF, 78 KB] (opens in new tab) |
04 Feb 2016 | Extraction Screw for PFNA Blade, Synthes GmbH (HSA 600:41/01-002/16/03_44) | HSA 6004101-002-16-03_44 FSN [PDF, 70 KB] (opens in new tab) |
03 Feb 2016 | Endobon®-Xenograft Granules 0.5 ml/1ml/2ml/5ml/8ml, Biomet 3i (HSA 600:41/01-181/16/01_41) | HSA 6004101-181-16-01_41 FSN [PDF, 433 KB] (opens in new tab) |
03 Feb 2016 | Digital Radiography X-Ray System DX-D 100, Agfa HealthCare N.V. (HSA 600:41/01-184/16/01_52) | HSA 6004101-184-16-01_52 FSN [PDF, 106 KB] (opens in new tab) |
02 Feb 2016 | Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202 and Trilogy EC Respironies, Inc. (HSA 600:41/01-287/16/01_40) | HSA 6004101-287-16-01_40 FSN [PDF, 4981 KB] (opens in new tab) |
01 Feb 2016 | TWINFIX 5.0 AB Suture Anchor w/Two 38” Ultrabraid Suture Needles and Threaded Dilator, Respironies, Inc. (HSA 600:41/01-073/16/05_36) | HSA 6004101-073-16-05_36 FSN [PDF, 61 KB] (opens in new tab) |
01 Feb 2016 | Endobutton CL BTB Sterile 30mm, Smith & Nephew Inc (HSA 600:41/01-073/16/04_49) | HSA 6004101-073-16-04_49 FSN [PDF, 55 KB] (opens in new tab) |